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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oximeter
Regulation Description Oximeter.
Product CodeDQA
Regulation Number 870.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
AVIDHRT, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVITA CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
BELUN TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
BIOBEAT TECHNOLOGIES , LTD.
  SUBSTANTIALLY EQUIVALENT 2
BODIMETRICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CHRONISENSE MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
COFOE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 2
DONGGUAN LINGXIN TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EMPATICA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG GENIAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG LONG YAO ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HINLAB, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUIZHOU XIAOOU TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JKH USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
LEADTEK RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 2
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
MOVANO INC. DBA MOVANO HEALTH
  SUBSTANTIALLY EQUIVALENT 1
NONIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OWLET BABYCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
OXIWEAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME
  SUBSTANTIALLY EQUIVALENT 1
S.L.P. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEMPULSE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI BERRY ELECTRONIC TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN AEON TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN BEST ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BRAV ELECTRONIC TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CREATIVE INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HEXIN ZONDAN MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN LEPU INTELLIGENT MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MECUN MEDICAL SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MERICONN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN NARIG BIO-MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN RAYSINTONE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SINO-K MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SMALLSIGNAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN VIATOM TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN WITLEAF MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN YIMI LIFE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YKD TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIBEL HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SUREPULSE MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
TRUE WEARABLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNIMED MEDICAL SUPPLIES, INC.
  SUBSTANTIALLY EQUIVALENT 9
VYVO TECHNOLOGY CORP.(VT)
  SUBSTANTIALLY EQUIVALENT 1
WESPER, INC.
  SUBSTANTIALLY EQUIVALENT 1
XINKANG MEDICAL INSTRUMENT CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI LINTE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 426 430
2021 553 558
2022 478 485
2023 392 394
2024 545 545
2025 407 407
2026 310 310

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 496 500
Low Readings 352 354
Device Alarm System 269 269
Unexpected Shutdown 259 261
Sensing Intermittently 240 240
High Readings 192 192
Image Display Error/Artifact 147 147
Patient Device Interaction Problem 146 146
Incorrect, Inadequate or Imprecise Result or Readings 115 118
Failure to Analyze Signal 113 113
Break 109 109
Inappropriate or Unexpected Reset 108 108
Temperature Problem 103 103
Crack 89 89
Unable to Obtain Readings 88 88
Corroded 72 72
Display or Visual Feedback Problem 58 58
Erratic or Intermittent Display 56 56
Communication or Transmission Problem 54 54
Appropriate Term/Code Not Available 45 45
Failure to Power Up 41 43
No Audible Alarm 40 40
Adverse Event Without Identified Device or Use Problem 33 34
Insufficient Information 32 32
Patient-Device Incompatibility 32 32
Defective Device 31 31
Circuit Failure 29 29
Contamination 27 27
Loose or Intermittent Connection 27 27
Noise, Audible 26 26
Delayed Program or Algorithm Execution 25 25
No Apparent Adverse Event 25 25
Failure to Read Input Signal 21 21
Device Damaged Prior to Use 20 20
No Display/Image 19 19
Device Displays Incorrect Message 19 23
Defective Component 18 18
Use of Device Problem 18 18
Mechanical Problem 15 15
Battery Problem 15 16
Charging Problem 13 14
Material Split, Cut or Torn 13 13
Application Program Freezes, Becomes Nonfunctional 13 13
Erratic Results 13 13
Computer Software Problem 13 13
Defective Alarm 12 12
Ambient Noise Problem 11 11
Device Sensing Problem 10 10
Failure to Sense 10 10
Failure to Run on Battery 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2127 2138
No Consequences Or Impact To Patient 277 277
Insufficient Information 269 274
No Patient Involvement 141 141
Pressure Sores 79 79
Burn(s) 53 53
Low Oxygen Saturation 40 40
Unspecified Tissue Injury 24 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Blister 22 22
Anxiety 18 18
Superficial (First Degree) Burn 13 13
Death 13 13
Skin Inflammation/ Irritation 10 10
Erythema 9 9
Cardiac Arrest 9 9
Hypoxia 8 8
Cyanosis 7 7
No Known Impact Or Consequence To Patient 7 7
Injury 6 6
Skin Discoloration 6 6
No Information 6 6
Electric Shock 6 6
Rash 5 5
Skin Erosion 5 5
Burning Sensation 5 5
Brain Injury 5 5
Ulcer 5 5
Inflammation 4 4
Pain 4 4
Bradycardia 4 4
Partial thickness (Second Degree) Burn 4 4
Respiratory Arrest 3 3
Abrasion 2 2
Burn, Thermal 2 2
Bruise/Contusion 2 2
Skin Disorders 2 2
Skin Burning Sensation 2 2
Ischemia 2 2
Chest Pain 2 3
Respiratory Failure 2 2
Dyspnea 2 2
Ventilator Dependent 2 2
Tachycardia 2 2
High Oxygen Saturation 2 2
Apnea 2 2
Convulsion/Seizure 2 2
Encephalopathy 2 2
Unintended Extubation 1 1
Full thickness (Third Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accriva Diagnostics, Inc. II Oct-31-2024
2 Covidien II Jul-21-2025
3 Edan Diagnostics II Jan-22-2026
4 Masimo Corporation II Apr-12-2024
5 Masimo Corporation II Jun-21-2023
6 Nihon Kohden America Inc II Oct-30-2024
7 SUREPULSE MEDICAL LTD III Feb-12-2026
8 Zoe Medical Incorporated II Sep-10-2024
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